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cGMP Monitoring System LMS Pharma – Vaxxas TRI Qld

TRI
The Translational Research Institute (TRI) is a unique, Australian-first initiative of ‘bench to bedside’ medical research. TRI combines clinical and translational research to advance progress from laboratory discovery to application in the community.

LAF tech was awarded the opportunity to deliver an Environmental Monitoring System that is intended to monitor GMP critical environmental conditions within the Vaxxas manufacturing facility located within the Translational Research Institute. Integrating Lighthouse LMS Pharma monitoring software  the system was designed on a single server architecture that monitors various environmental conditions including oxygen levels. Part of our earlier scope was to supply, install and commission a large ceiling grid Grade A Laminar Flow system in which to provide a Grade A (ISO 4.8) air cleanliness level work zone.

Lighthouse proprietary brand Relative humidity and temperature sensors and Sensocon A2 series Differential pressure sensors were utilised for accurate environment monitoring.

LMS Pharma is assigned as a GAMP (category 4) or configurable product and enables compliance with 21 CFR Part 11.

The particles are monitored utilising Lighthouse R5104P Remote Particle Counters. These instruments have internal network controlled vacuum pumps, eliminating the requirement for a central vacuum system.

This LMS Pharma system is configured with the ability to send email and SMS notifications when alarm conditions or faults occur. A dedicated 4G Modem was installed, enabling SMS notifications.

Project delivered in September 2017.

LAF tech continues to support the system ongoing providing both onsite onsite and remote technical support.  Our in-house NATA accredited Laboratory routinely receives the clients Lighthouse Remote and Hand Held Particle counters for annual ISO 21501-4 calibration service.

Another LAF tech Project with Our Australian industry Standard Lighthouse LMS Pharma Software (SCADA) with Lighthouse Remote Particle counters.

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